Investigation of Non-Invasive Pulsed Electromagnetic Field (PEMF) Therapy for Female Patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

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PROJECT SUMMARY The goal of this pilot and feasibility clinical trial is to acquire preliminary data regarding the safety and efficacy of the non-invasive pulsed electromagnetic field (PEMF) therapy for pain management in interstitial cystitis/bladder pain syndrome (IC/BPS) patients. We present preliminary data suggesting that IC/BPS comprises at least two distinct phenotypic subpopulations; one characterized as a bladder-centric disease process and the other characterized as a non-bladder-centric systemic pain syndrome. We propose to leverage our large patient database to recruit patients into this clinical trial wherein we will test the safety and efficacy of PEMF therapy. The trial will employ a single-site, randomized, double-blind, sham placebo-controlled study design. To accomplish the goals of this clinical trial, we propose the following three Specific Aims. Specific Aim 1: Determine the impact of PEMF therapy on pain reduction in IC/BPS patients. From our registry of 488 IC/BPS patients we will recruit 60 adult female patients who have met all inclusion/exclusion criteria, that includes: (1) 30 patients with an anesthetic BC≤400 anesthetic (i.e., bladder centric phenotype), and (2) 30 patients with an anesthetic BC>400 cc (i.e., those with a non-bladder centric (systemic) phenotype); all having a current numeric rating scale (NRS) pain score of ≥6. Patients within each of the two phenotypic groups will be randomly assigned (1:1 ratio) to either the PEMF treatment or sham group, trained in the clinic on the use of the PEMF device, and then undergo twice daily PEMF therapy (or sham) sessions at home for four weeks. The sham device is identical in every way to the treatment devices except it does not deliver a pulsed electromagnetic field. Patients will be assessed at enrollment, at follow-up after the 4-week treatment period, and then monthly for the next 3 months. The primary outcome measure will be a significant change in their pelvic pain score (i.e., a decrease ≥ 2). Secondary outcomes will be assessed by validated IC/BPS questionnaires (O’Leary-Sant), voiding characteristics (voiding diary), Brief Pain Inventory (BPI) Short Form, Pelvic Pain and Urgency/Frequency (PUF) Patient Symptom Scale, and Global Response Assessment (GRA). Specific Aim 2: Determine the duration of benefit from PEMF therapy with and without maintenance treatments. An additional cohort of 15 adult female patients with non-bladder centric IC/BPS will be recruited and undergo the standard 4-week regimen, followed by a one-week-per-month of twice daily PEMF therapy regimen for an additional 3 months. Primary and secondary outcomes will be assessed monthly, out to 4 months, as described in Aim 1. The results will be compared to the non-bladder centric patients treated for 4 weeks only in Aim 1. If results from Aim 1 show that there is no difference in the positive response between the two groups, or that PEMF therapy benefits bladder-centric patients more than non-bladder centric patients, then the patient make-up for Aim 2 will be adjusted accordingly (i.e., 8 patients from each group (N=16), or all 15 will be bladder- centric, respectively) and the comparator group(s) will be adjusted accordingly.